
[Federal Register Volume 75, Number 224 (Monday, November 22, 2010)]
[Notices]
[Page 71133]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-29292]



[[Page 71133]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0571]


Guidance for Industry: The Safety of Imported Traditional Pottery 
Intended for Use With Food and the Use of the Term ``Lead Free'' in the 
Labeling of Pottery; and Proper Identification of Ornamental and 
Decorative Ceramicware; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Guidance for Industry: The Safety 
of Imported Traditional Pottery Intended for Use With Food and the Use 
of the Term `Lead Free' in the Labeling of Pottery; and Proper 
Identification of Ornamental and Decorative Ceramicware.'' FDA is 
issuing the guidance in response to recent findings of lead 
contamination of imported traditional pottery labeled as ``Lead Free.'' 
The guidance identifies several key practices that manufacturers of 
pottery may implement to help ensure that lead contamination of non-
lead glazed (NLG) pottery will not occur and also reminds manufacturers 
of existing requirements for properly labeling certain ornamental and 
decorative ceramicware as not for use for food-handling purposes.

DATES: Submit either electronic or written comments on the guidance at 
any time.

ADDRESSES: Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit written requests for single 
copies of the guidance to the Office of Food Safety, Center for Food 
Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740. Send two self-
addressed adhesive labels to assist that office in processing your 
request. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance.

FOR FURTHER INFORMATION CONTACT: Michael E. Kashtock, Center for Food 
Safety and Applied Nutrition (HFS-317), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2022.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``The 
Safety of Imported Traditional Pottery Intended for Use With Food and 
the Use of the Term `Lead Free' in the Labeling of Pottery; and Proper 
Identification of Ornamental and Decorative Ceramicware.'' FDA is 
issuing the guidance in response to recent findings of lead 
contamination of imported traditional pottery labeled as ``Lead Free.'' 
This contamination is occurring even with the use of newer production 
practices that do not utilize intentionally added lead (e.g., the use 
of non-lead glazes). The guidance identifies several key practices that 
manufacturers of pottery may implement to help ensure that lead 
contamination of NLG pottery will not occur and also reminds 
manufacturers of existing requirements for properly labeling certain 
ornamental and decorative ceramicware items as not for use for food-
handling purposes.
    FDA is issuing this guidance as level 1 guidance. Consistent with 
FDA's good guidance practices regulation (21 CFR 10.115), the Agency 
will accept comments, but is implementing the guidance document 
immediately, in accordance with 21 CFR 10.115(g)(2), because the Agency 
has determined that prior public participation is not feasible or 
appropriate in light of the need to respond expeditiously to numerous 
recent reports of lead contamination of imported traditional pottery. 
The guidance represents the Agency's current thinking on food safety 
considerations relevant to lead contamination of NLG traditional 
pottery, and labeling considerations for food use and non food use 
pottery that may contain lead. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternate approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding the 
guidance. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
http://www.fda.gov/FoodGuidances or http://www.regulations.gov.

    Dated: November 5, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29292 Filed 11-19-10; 8:45 am]
BILLING CODE 4160-01-P


